Apr. 13, 2013

Written by

The Tennessean

The U.S. Food and Drug Administration positioned itself as a more assertive agency pushing the boundaries of its power to police compounding labs this week, while representatives of pharmaceutical companies disputed FDA claims that they tried to deny its inspectors proper access.

The back-and-forth occurred just days before FDA Commissioner Margaret Hamburg’s scheduled testimony Tuesday before a congressional committee. Committee members from opposing political parties claimed to have new information that either proved the FDA failed to prevent the fungal meningitis outbreak or showed how the pharmaceutical industry had clipped its authority.

The FDA released information about 31 recent inspections of compounding pharmacies — one of which resulted in a large recall by a Nevada-based firm licensed to sell drugs in Tennessee and another that pointed out issues with a Memphis compounder.

Green Valley Drugs, based in Henderson, Nev., recalled all of its sterile products after the FDA documented sterility issues.

Those products include methylprednisolone acetate — the same drug New England Compounding Center made that was linked to the nationwide outbreak of fungal meningitis. However, Green Valley said it had received no reports of injuries from its products. The recall comes after a round of surveillance inspections by the FDA.

Hamburg said some compounders had refused access to inspectors to fully assess quality and sterility issues. The agency got federal court orders to finish inspections on two of those compounders, Florida-based Olympia Pharmacy and New Jersey-based Wedgewood Village Pharmacy Inc.

Scott Livingston, a lawyer for Olympia, said the pharmacy did grant the FDA access to its laboratory but not to all the records the agency wanted. Olympia provided documents with some of the information redacted.

“This was not sufficient for the inspectors,” Livingston said. “Olympia then entered into discussions with the FDA’s counsel to resolve the issue, requesting the statutory authority allowing the FDA to receive copies of confidential documents. Without concluding the discussions, the FDA went before a local magistrate judge and acquired an administrative warrant.”

Marcia Bliss, president of Wedgewood Village Pharmacy, said her company cooperated fully with the FDA until the agency asked for financial records.

“After the initial inspections, the FDA began to request records that they were specifically not allowed by law to request, and they were requests not related to quality — for example, financial records,” Bliss said.

Her company sent a letter to the FDA’s state office in New Jersey and asked for an opportunity to meet and talk about the issue. The office never responded to the request, she said. Company representatives later told FDA inspectors they would need a warrant, she said.

“The judge who issued the warrant specifically denied the FDA’s request to examine those business and financial records. ... It granted the FDA access to what we were already providing the FDA,” Bliss said.

Second appearance

Hamburg’s appearance Tuesday will be her second time before a U.S. House of Representatives committee investigating the outbreak. On Thursday, four Democrats on that committee sent a letter to the Republican chairman requesting that David Miller, head of the International Academy of Compounding Pharmacists, also testify.

But the Republicans who lead the committee released a statement Friday saying they have FDA documents that show the agency dropped the ball.

“The documents we have gathered over the last six months paint a disturbing picture of how the FDA let the American people down,” Reps. Fred Upton and Tim Murphy said in a joint news release.

However, they also said that, with the recent round of inspections, “it seems the FDA is finally doing its job and inspecting large-scale compounding operations with lengthy rap sheets.”

Green Valley Drugs’ recalled products encompass a list numbering 17 pages. The company said the recall of its sterile products was “based on observations of clean room personnel and certain aseptic techniques.” It said although independent outside testing laboratories had not detected contaminants in its packaged drugs, it was doing the recall out of an abundance of caution.

The FDA had not posted its inspection report of Green Valley Drugs as of Friday morning.

It does have a report online for Memphis-based PharMEDium Services, which was inspected in mid-March. Inspectors said employees leaned over processing areas for injectables with facial hair exposed and continually rested their hands on work surfaces without resanitizing their hands. And the FDA said the company did not do tests to ensure safety.

A drug supplier based in Bristol, Tenn., also did a more limited recall this year because of a sterility issue. Dr. Reddy’s Laboratories Tennessee LLC recalled lots of the antibiotic amoxicillin in February because of microbial contamination.